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TAR POMADE

Information leaflet

                                                    Irish Medicines Board




                                                        Part II
                                Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Tar Pomade

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 Coal tar solution        6.0% w/w
 Salicylic Acid           2.0% w/w

 3 PHARMACEUTICAL FORM

 Light brown coloured ointment.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic Indications

 It is recommended for use in the treatment of eczema, psoriasis and related skin affections.

 4.2 Posology and method of adminstration

 Dosage

 Apply to the affected area as directed by the pharmacist and/or the physician.
 Administration

 Cutaneous (topical) use.

 4.3 Contraindications

 Use in persons hypersensitive to any of the ingredients.

 4.4 Special warnings and special precautions for use

 If the condition does not improve, or is aggravated consult the doctor.

 Exposure of the treated areas to direct sunlight should be avoided after application.

 Avoid contact with eyes.

 4.5 Interaction with other medicinal products and other forms of interaction

 No interactions known.

 4.6 Pregnancy and lactation

 Use in pregnancy and lactation has not been established for this product, however, due to the established nature of the
 ingredients, no adverse effects are anticipated.




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Date Issued 15/11/2005                                CRN 2016847                                         page number: 1
                                                    Irish Medicines Board




 4.7 Effects on ability to drive and use machines

 None.

 4.8 Undesirable effects

 None.

 4.9 Overdose

 Not applicable.

 5 PHARMACOLOGICAL PROPERTIES

 5.1 Pharmacodynamic properties

 Tar pomade has antipruritic, keratolytic and antiseptic properties.

 5.2 Pharmacokinetic properties

 Not relevant.

 5.3 Preclinical safety data

 Coal Tar

 Skin and eye irritation:

 Skin (human): 15 µg/3D-1        Mild
 Skin (rabbit): 5%/3H            Mild

 Salicylic Acid

 Skin and eye irritation:

 Skin (rabbit)     500 mg/24H Mild
 Eye (rabbit)      100 mg Severe

 Skin (man):       TDLo: 57 mg/kg Sense organs and special senses

 (Registry of Toxic Effects of Chemical Substances 1985-86)

 6 PHARMACEUTICAL PARTICULARS

 6.1 List of excipients

 Emulsifying wax
 Yellow soft paraffin
 Liquid paraffin
 Polysorbate 80

 6.2 Incompatibilities

 Not applicable.




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Date Issued 15/11/2005                                CRN 2016847                                         page number: 2
                                                  Irish Medicines Board




 6.3 Shelf Life

 3 years.

 6.4 Special precautions for storage

 Do not store above 25°C.

 6.5 Nature and contents of container

 Plastic jar.
 100 g.
 400 g.

 6.6 Instructions for use and handling

 None.

 7 MARKETING AUTHORISATION HOLDER

 Foran Chemical Limited,
 2 Cherry Orchard Industrial Estate,
 Dublin 10.

 8 MARKETING AUTHORISATION NUMBER

 PA 484/26/1

 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 Date of first authorisation: 29th January 1991
 Date of last renewal: 29th January 2001

 10 DATE OF REVISION OF THE TEXT

 December 2001




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Date Issued 15/11/2005                                CRN 2016847                                         page number: 3
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